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Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

Last updated on June 27, 2019

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Study Location
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Ineligibility for participation in any ongoing clinical study of the investigational
product

- Age ≥18 years

- Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK
rearrangement or a ROS1 rearrangement

- For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If
prior ALK-TKI was crizotinib, additional prior treatment required with at least one
second generation ALK-TKI registered and commercially available. For patients with
resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance
mutation), prior treatment with an ALK/ROS1 inhibitor is not required.

- For ROS1 positive patients: failure to prior treatment with at least crizotinib

- Adequate bone marrow, liver, renal, pancreatic functions

- Negative pregnancy test at screening

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or
participation in other studies with investigational drugs within the timeframe
indicated in the protocol

- History of interstitial fibrosis or interstitial lung disease

- Concomitant use of prohibited medication

- Clinically significant cardiovascular disease: cerebral vascular accident/stroke,
myocardial infarction, unstable angina, congestive heart failure, second degree or
third degree atrioventricular block (unless paced) or any AV block with PR >220 msec

- Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with
QTc >470 msec, or congenital long QT syndrome

- History of or predisposing characteristics for acute pancreatitis

NCT03178071
Pfizer
No longer available
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

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